The present invention relates to a nutritional composition suitable to treat or alleviate side-effects of treatment of cancer by chemotherapy or radiotherapy, both during and after such therapy. The invention also relates to a method for treating or preventing side effects of chemotherapy or radiotherapy.
Chemotherapy and radiotherapy are effective at destroying tumours because they target cells with high proliferation rates and hence fast growing tissues. Since stem cells of the gastrointestinal tract have high proliferation rates, too, a problematic side effect of chemotherapy or radiotherapy is the premature death of dividing epithelial cells.
In particular, chemotherapy and radiotherapy, which are often the treatments of choice for cancer patients, may be associated with symptoms of intestinal impairment such as nausea, vomiting, diarrhoea, with or without blood in the stools (ulceration) and abdominal pain. These symptoms are linked to damages of the intestinal mucosa, the epithelial cell layer lining the intestines, which is in direct contact with the contents of the gastro-intestinal tract. During chemotherapy, the gastro-intestinal tract often contains anti cancer drugs, which may induce dietary intolerance and mucositis. Stomatitis is also frequently observed, and, together with diarrhoea, this strongly hampers the quality of life of the patient.
Several products on the market are communicated to be beneficial for cancer patients. For example PROSURE™, which is commercialised by Abbott Laboratories is a ready-to-drink (rtd) beverage with an energy density of about 1.27 kcal/ml, about 21% of energy being provided by protein. Furthermore, the product has 0.021 g fibre per ml. However, a nutritional composition, which is even higher in energy and provides more protein may prove to be advantageous over this product.
RESOURCE SUPPORT™, a rtd drink commercialised by Novartis, has about 1.52 kcal/ml and 23.3% energy provided by protein. This formula has 0.127 g fibre per ml. It is an objective of the present invention to provide unique protein blends and a good taste adapted to cancer patients, while avoiding the presence of ingredients, which are present in amounts insufficient to be effective.
B van't Land et al, “Transforming Growth Factor-β2 protects the small intestine during methotrexate treatment in rats possibly by reducing stem cell cycling”, British Journal of Cancer (2002) 87, 113-118, report that TGF-β2 isolated from bovine milk may reversibly arrest growth of epithelial stem cells during therapy. In a rat model, oral supplementation of rats exposed to methotrexate with TGF-β2 reduced the chemotherapy-associated weight loss.
WO 96/34614 discloses a method for preventing the damage that chemotherapy causes to the lining of the alimentary tract, by administering an effective amount of a milk product extract. This extract comprises GFE-2 (Growth Factor Extract), which is isolated from whey and nearly free of casein.
U.S. Pat. No. 5,824,297 discloses the use of TGF-β3 for inhibiting cytotoxic poisoning due to anti-neoplastic therapy such as radiation treatment or chemotherapy. TGF-β3 is administered topically. U.S. Pat. No. 5,824,297 does not disclose a nutritional composition.
A food composition including colostrum-derived growth factors is disclosed in WO 99/56758, whereby the composition is administered to prevent a disorder of the gut, for example, resulting from chemotherapy. However, colostrum can be obtained only during a short period of time after birth of the calf. Furthermore, WO 99/56758 does not disclose an embodiment of a nutritionally complete composition.
In view of the prior art, it is an objective of the present invention to provide a nutritional composition, which is suitable to provide macro-nutrients and micro-nutrient and which prevents and/or alleviates mucosal damage, in particular those resulting from radiation or chemotherapy.
It is a particular objective to provide a good-tasting nutritional composition, which is suitable to promote weight gain in patients undergoing radiation- or chemotherapy. This objective is important in light of the fact that cancer patients that are chemically or radiation treated often have different taste preferences when compared to non-treated persons.
It is an objective of the present invention to provide nutrition and to prevent and/or treat side effects of chemotherapy or radiotherapy, for example with cancer patients.
Moreover, it is an objective to provide bio-active proteins derived or obtained from milk, which are able to remain active during passage through the gastro-intestinal tract.
It is an objective to provide a nutritional composition, comprising macro-nutrients, such as milk protein, which at the same time comprise bio-active proteins in effective quantities.
It is a further objective of the present invention to provide a nutritional supplement, for example a complete nutritional supplement.